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Active, Not Recruiting

NCT Number: NCT05529901

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryptogenic Stroke Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Ischemic Stroke Nervous System Diseases PFO - Patent Foramen Ovale TIA Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Okayama University Hospital

Okayama, 700-8558, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
  • Diagnosed with a PFO
  • Note: Additional Inclusion Criteria may apply

Exclusion criteria

  • N/A

Treatment and study plan

GORE® CARDIOFORM Septal Occluder

Device

Patients for whom the device is used (implanted or used by not implanted) during the enrollment period of this post-marketing surveillance will be considered eligible for the study

Primary outcomes

  1. PFO Closure Rate

    Time frame: 12 months

    PFO closure success will be defined as the number of cases which achieve effective PFO closure at 12 months post-initial procedure out of those which complete the PFO closure evaluation under Trans-Thoracic Echocardiography (TTE) with bubbles. PFO effective closure will be defined as the number of bubbles confirmed to be less than 20 (<20).

  2. Rate of Conversion to surgical procedure

    Time frame: Discharge

    Rate of post-procedure conversion to surgical procedure will be calculated.

  3. Incidence rate of post-procedure ischemic stroke events

    Time frame: 36 months

    Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot.

  4. Device success

    Time frame: 36 months

    Device success will be calculated by the number of cases with successful device implant during the initial procedure and later follow-ups out of those which underwent the transcatheter PFO closure procedure.

  5. Incidence rate of post-procedure adverse events and/or device issues

    Time frame: 36 months

    Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated.

  6. Incidence rate of device- and procedure-related events within 30 days post procedure

    Time frame: 30 days

    Incidence rate of adverse events and/or device issues which are defined as device- or procedure-related within 30 days post procedure will be calculated.

Other outcomes

  1. Incidence rate of post-procedure Atrial fibrillation

    Time frame: 36 months

    Rate of post-procedure AF will be calculated during each follow-up period.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Acronym: GSO-PFO PMS

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Sep 7, 2022
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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